Recruiting

Ciltacabtagene AutoleucelA Long-term Study for Participants Previously Treated With Ciltacabtagene Autoleucel

Sponsor:

Janssen Research & Development, LLC

Code:

NCT05201781

Conditions

Multiple Myeloma

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Cilta-cel

Study Details

Brief summary:

The purpose of this study is to collect long-term follow-up data on delayed adverse events after administration of ciltacabtagene autoleucel (cilta-cel), and to characterize and understand the long-term safety profile of cilta-cel.

Conditions

Multiple Myeloma

Study ID

NCT05201781

Start date

Mar 9, 2022

Status verified date

Aug, 2026

Completion date

Jun 28, 2041

Anticipated

Primary completion date

Jul 29, 2037

Anticipated

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

Participants who have received at least one dose of cilta-cel in a Company-sponsored clinical study
Participants who have provided informed consent for this study

Study Design

Enrollment

295 participants

Anticipated

Intervention Model

Single group

Primary purpose

Other

Interventions and Outcome Measures

Arms

experimental: Cilta-cel

Participants who had previously received treatment with cilta-cel in a Company-sponsored clinical study (example, NCT04923893, NCT03758417, NCT04181827, NCT05347485, NCT04133636, and NCT03548207) in the global development program will be enrolled into this study once the individual's participation in the particular interventional study has ended or a study has been terminated. Participants will not receive any treatment in this study and will be followed-up at least once per year on delayed adverse events for up to 15 years after receiving the last dose of cilta-cel.

Interventions

Cilta-cel

Participants who had received cilta-cel in previous studies will be followed up in this study. No additional study treatment will be administered to participants in this study.

Primary outcome measure

Number of Participants with New Malignancies and Recurrence of Pre-existing Malignancy [ Time Frame: Up to 15 years ]
Number of Participants with New Incidence or Exacerbation of a Pre-existing Neurologic Disorder [ Time Frame: Up to 15 years ]
Number of Participants with New Incidence or Exacerbation of a Pre-existing Rheumatologic or Other Autoimmune Disorder [ Time Frame: Up to 15 years ]
Number of Participants with New Incidence of Grade Greater than or Equal to (>=) 3 Hematologic Disorder Including Hypogammaglobulinemia [ Time Frame: From year 1 up to year 5 ]
Number of Participants with Serious Hematologic Disorder, including Hypogammaglobulinemia [ Time Frame: From year 6 up to year 15 ]
Number of Participants with New Incidence of Grade >= 3 Infection [ Time Frame: From year 1 up to year 5 ]
Number of Participants with Serious Infection [ Time Frame: From year 6 up to year 15 ]
Number of Participants with Serious Adverse Events (SAEs) [ Time Frame: From year 1 up to year 5 ]
Number of Participants with Related Serious Adverse Events Assessed by the Investigator [ Time Frame: From year 6 up to year 15 ]

Central Contacts and Locations

Central contacts

Study Contact

844-434-4210 Participate-In-This-Study1@its.jnj.com

Locations

Mayo Clinic Cancer Center-Scottsdale

Recruiting

Phoenix, Arizona, United States, 85054

City of Hope

Recruiting

Duarte, California, United States, 91010

University of California San Francisco

Recruiting

San Francisco, California, United States, 94143

Stanford University Medical Center

Recruiting

Stanford, California, United States, 94305-5623

Moffitt Cancer Center

Recruiting

Tampa, Florida, United States, 33612

Emory University

Recruiting

Atlanta, Georgia, United States, 30322

Northwestern University

Recruiting

Chicago, Illinois, United States, 60611

University of Chicago

Recruiting

Chicago, Illinois, United States, 60637

Indiana University

Recruiting

Indianapolis, Indiana, United States, 46202

Kansas University Medical Center

Recruiting

Westwood, Kansas, United States, 66205

Dana Farber Cancer Institute

Recruiting

Boston, Massachusetts, United States, 02115

Beth Israel Deaconess Medical Center

Recruiting

Boston, Massachusetts, United States, 02215

Massachusetts General Hospital

Recruiting

Boston, Massachusetts, United States, 02215

Barbara Ann Karmanos Cancer Institute

Recruiting

Detroit, Michigan, United States, 48201

Mayo Clinic Rochester

Recruiting

Rochester, Minnesota, United States, 55902

Washington University School Of Medicine

Recruiting

St Louis, Missouri, United States, 63110

Hackensack University Medical Center

Recruiting

Hackensack, New Jersey, United States, 07601

Rutgers Cancer Institute of New Jersey

Recruiting

New Brunswick, New Jersey, United States, 08903

Roswell Park Cancer Institute

Recruiting

Buffalo, New York, United States, 14263

Mount Sinai Medical Center

Recruiting

New York, New York, United States, 10029

Memorial Sloan Kettering Cancer Center

Recruiting

New York, New York, United States, 10065

Montefiore Medical Center

Recruiting

The Bronx, New York, United States, 10467

Levine Cancer Institute

Recruiting

Charlotte, North Carolina, United States, 28204

University of Pennsylvania

Recruiting

Philadelphia, Pennsylvania, United States, 19104

University of Pittsburgh Medical Center

Recruiting

Pittsburgh, Pennsylvania, United States, 15232

Sarah Cannon Research Institute

Recruiting

Nashville, Tennessee, United States, 37203

MD Anderson Cancer Center

Recruiting

Houston, Texas, United States, 77030

Froedtert Memorial

Recruiting

Milwaukee, Wisconsin, United States, 53226

More Information

Sponsor

Janssen Research & Development, LLC

Last update posted

Aug 28, 2026

Last verified

Aug, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by Janssen Research & Development, LLC on 2026-08-28.